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Clinical Trials/NCT04026035
NCT04026035
Completed
Not Applicable

PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.

University Hospital, Bordeaux1 site in 1 country51 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septicemia in Hemodialysis
Sponsor
University Hospital, Bordeaux
Enrollment
51
Locations
1
Primary Endpoint
Estimate the bacterial species concordance between the diagnostic laboratory approach and the novel approach
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.

Detailed Description

The outlook of current trends indicates that maximum effort is needed to tailor the initial antimicrobial therapy in patients under hemodialysis with catheter. Specific emphasis is put on early availability of antimicrobial susceptibility results by Diagnostic laboratories to optimize the management of those difficult infections. Direct whole blood PCR could allow a rapid determination of bacterial susceptibility to antibiotics. The study is designed to assess the concordance of a direct whole blood PCR targeting staphylococcus and its susceptibility to oracillin with the classical microbiological approach of samples from hemodialysis patients with catheter suspected of septicemia. This innovative approach should allow a faster diagnostic allowing the clinicians to better tailor the initial empirical antimicrobial therapy which has been proven crucial for a good clinical management of the patients. Moreover, the use of an adequate antimicrobial therapy early in the management of the patients, should not only lead to a better clinical outcome but also avoid unnecessary prescriptions of drugs which are the main drivers of the emergence and spread of antimicrobial resistance.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
March 5, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients over 18 year old,
  • suspicion of septicemia in hemodialysis patient with catheter,
  • patient oral consent prior to inclusion in the study.

Exclusion Criteria

  • patients who went through the A\&E department,
  • patients who have received an antimicrobial therapy more than 8 hours long,
  • patient under legal protection.

Outcomes

Primary Outcomes

Estimate the bacterial species concordance between the diagnostic laboratory approach and the novel approach

Time Frame: 48 hours after inclusion visit

The bacterial contamination will be estimated by the results of hemoculture compared to the PCR approach. The concordance between the two profils will be observed.

Secondary Outcomes

  • Evaluate the concordance of meticillin resistance diagnosis between PCR and blood cultures(48 hours after inclusion visit)

Study Sites (1)

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